London-based LivaNova has received US Food and Drug Administration (FDA) 510(k) clearance, as well as the European Commission’s CE Mark, for its Essenz In-Line Blood Monitor, which provides continuous measurement of blood parameters to perfusionists throughout cardiopulmonary bypass procedures.
The blood monitor is integrated into LivaNova’s next-generation cardiopulmonary bypass platform, the Essenz Perfusion System, which allows perfusionists to access and manage blood parameters directly from the system’s cockpit without the need for additional monitors or holders.
With the Essenz In-Line Blood Monitor, perfusionists receive in-line continuous monitoring of the patient’s parameters for the duration of a procedure. This allows for the delivery of a patient-tailored approach to perfusion rooted in data-driven decisions, according to a release from LivaNova.
“Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” says Marco Dolci, LivaNova’s president of cardiopulmonary, in a release. “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure. Access to accurate, real-time measurements directly from the Essenz Perfusion System allows for quick decisions and tailored care strategies to serve the patient.”
Powered by B-Capta sensing technology, the blood monitor works within Clinical Laboratory Improvement Amendments guidelines and provides parameter values in line with hospital blood gas analyzers, even prior to alignment. To enable accurate monitoring, the blood monitor provides measured values for oxygen saturation, hematocrit, partial pressure of oxygen, and temperature, rather than calculated values for these parameters.
In addition, the blood monitor requires no calibration to set device measurements, allowing the perfusionist to save time during device setup, especially in emergency cases. Arterial and venous parameters are automatically transferred to the Essenz Patient Monitor, supporting data-driven decision-making and the implementation of goal-directed perfusion, a therapy effective in reducing the risk of acute kidney injury, according to a release from LivaNova.
The latest heart-lung machine software, version 1.3, integrates the in-line blood monitor with the Essenz Perfusion System. The Essenz Perfusion System consists of a next-generation heart-lung machine, a patient monitor, and sensing technology that now includes the in-line blood monitor.
The Essenz Perfusion System, which launched in February, is currently available in Europe, the US, Canada, Australia, Japan, and the United Arab Emirates.
Photo caption: Essenz In-Line Blood Monitor shown with the Essenz Perfusion System
Photo credit: Business Wire